LUBRICANT EYE DROPS- sodium hyaluronate solution/ drops

Lubricant Eye Drops by

Drug Labeling and Warnings

Lubricant Eye Drops by is a Otc medication manufactured, distributed, or labeled by MFB Global LLC, DrSignal BioTechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Hyaluronate 1%

PURPOSE

Lubricant

DOSAGE & ADMINISTRATION

For the temporary relief of burning and irritation due to dryness of the eye.

For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.

For use as a protectant against further irritation or to relieve dryness of the eye.

For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

Relieves redness of the eye due to minor eye irritations.

WARNINGS

For external use only

DO NOT USE

if solution changes color or becomes cloudy.

USER SAFETY WARNINGS

if you have narrow angle glaucoma.

WHEN USING

To avoid contamination, do not touch tip of container to any surface. ■ Replace cap after using. ■ Overuse of this product may produce increased redness of the eye. ■ Pupils may become enlarged temporarily.

ASK DOCTOR

if ■ you experience eye pain, changes in vision, continued redness or irritation of the eye. ■ the symptom worsens or persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help of contact a Poison Control Center right away.

INDICATIONS & USAGE

Instill 1 or 2 drops in the affected eye(s) as needed up to four times daily.

OTHER SAFETY INFORMATION

Keep refrigerated. Store at 4-10℃(39-50℉). ■ Tamper Evident. Do not use if ring around the bottom of bottle cap is broken or missingminor eye irritations.

INACTIVE INGREDIENT

Polyquaternium 1

Purified Water.

88436-1 - Section Title Not Found In Database

1-646-339-5789

SPL UNCLASSIFIED SECTION

Manufacturer: DrSignal BioTechnology Co., Ltd. (No. 2-1, Ln. 181, Sec. 2, Jiuzong Rd., Neihu Dist., Taipei City 114, Taiwan)
Distributor: MFB Global LLC
(136-17 39th Ave Suite 301, Flushing, NY 11354, USA) Tel: 1-646-339-5789

Made in Taiwan

DESCRIPTION

product information

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LUBRICANT EYE DROPS 
sodium hyaluronate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82357-1101
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY)	HYALURONATE SODIUM	3 g  in 100 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLIDRONIUM CHLORIDE (UNII: 6716Z5YR3G)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82357-1101-2	1 in 1 BOX	11/05/2021
1	NDC: 82357-1101-1	3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/05/2021

Labeler - MFB Global LLC (118369923)

Registrant - DrSignal BioTechnology Co., Ltd. (656113584)

Establishment
Name	Address	ID/FEI	Business Operations
DrSignal BioTechnology Co., Ltd.		656113584	manufacture(82357-1101)